# K934382: Vci Suction/Irrigation Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Vital Concepts, Inc.
- Decided: Feb 1, 1994 after 145 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970946: Medline Y-Type Tur/Bladder Irrigation Set (1997), 1 descendant of its own
- K070873: Amsure Bladder Irrigation Set (2007), 0 descendants of its own

## Recalls of this device
- Nov 7, 2003 · Not classified · Z-0261-04: The probe may separate from the cannula.
- Nov 7, 2003 · Not classified · Z-0260-04: The probe may separate from the cannula.
- Nov 7, 2003 · Not classified · Z-0258-04: The probe may separate from the cannula.
- Nov 7, 2003 · Not classified · Z-0259-04: The probe may separate from the cannula.
- Jul 11, 2003 · Not classified · Z-0022-04: The suction valve may become stuck in the 'suction on' position under vacuum.
- Jul 11, 2003 · Not classified · Z-0025-04: The suction valve may become stuck in the 'suction on' position under vacuum.
- Jul 11, 2003 · Not classified · Z-0020-04: The suction valve may become stuck in the 'suction on' position under vacuum.
- Jul 11, 2003 · Not classified · Z-0021-04: The suction valve may become stuck in the 'suction on' position under vacuum.
- Jul 11, 2003 · Not classified · Z-0023-04: The suction valve may become stuck in the 'suction on' position under vacuum.
- Jul 11, 2003 · Not classified · Z-0024-04: The suction valve may become stuck in the 'suction on' position under vacuum.

Source page: https://510kreport.com/device/K934382
Methodology: https://510kreport.com/methodology